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ReceptIVFity & Immunology in ART

NCT06709976 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-12-09

No results posted yet for this study

Summary

The goal of this clinical non-invasive observational pilot study is to improve the prediction of pregnancy success after In Vitro Fertilisation (IVF)/IVF -Intracytoplasmic Sperm Injection (ICSI) treatment by examining the vaginal microbiome and the immunological profile of menstrual blood in women (18-42) years old) undergoing their first IVF/IVF/ICSI treatment.

The main questions it aims to answer are:

What is the ReceptIVFity profile (low, medium, or high) of the vaginal microbiome in these women? How do the endometrial-derived lymphocytes respond to different immune stimuli and microbiota? Can the endometrial stromal cells decidualize effectively in the presence or absence of specific microbiota?

Participants will:

Self-perform a vaginal swab to determine the ReceptIVFity profile of their vaginal microbiome.

Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours for immunological analysis.

Conditions

  • Infertility (IVF Patients)
  • Infertility Assisted Reproductive Technology

Interventions

DEVICE

Vaginal microbiome swab

All swabs were collected using FLOQSwabs™ (Copan Italia SpA, Brescia, Italy). The patients were instructed to spread the labia with one hand, insert the swab 3-5 cm beyond the vaginal orifice with the other hand, and rotate the swab along the vaginal wall for 10-15 seconds.

DEVICE

Menstrual Blood Collection via Menstrual Cup

Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-06
Primary Completion
2025-08-01
Completion
2025-12-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06709976 on ClinicalTrials.gov